[Federal Register Volume 76, Number 120 (Wednesday, June 22, 2011)]
[Rules and Regulations]
[Pages 36367-36369]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-15617]



[[Page 36367]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 100

RIN 0906-AA74


National Vaccine Injury Compensation Program: Revisions to the 
Vaccine Injury Table

AGENCY: Health Resources and Services Administration (HRSA), HHS.

ACTION: Final rule.

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SUMMARY: On September 13, 2010, the Secretary of Health and Human 
Services (the Secretary) published in the Federal Register a Notice of 
Proposed Rulemaking (NPRM) proposing changes to the regulations 
governing the National Vaccine Injury Compensation Program (VICP). 
Specifically, the Secretary proposed revisions to the Vaccine Injury 
Table (Table) to create distinct listings for hepatitis A, trivalent 
influenza, meningococcal, and human papillomavirus vaccines. The 
Secretary is now making this amendment to the Table by final rule; it 
is technical in nature. The four categories of vaccines described in 
this final rule are already covered vaccines under the VICP (starting 
in 2004) and are currently listed in a placeholder category (box XIII) 
in the Table. This final rule will list these vaccines as separate 
categories on the Table, with no associated injuries noted at this 
time, in order to help the public identify clearly that these vaccines 
are covered by the VICP. The changes implemented here are authorized by 
section 2114(e) of the Public Health Service Act (the Act).

DATES: This regulation is effective July 22, 2011.

FOR FURTHER INFORMATION CONTACT: Geoffrey Evans, M.D., Director, 
Division of Vaccine Injury Compensation, Healthcare Systems Bureau, 
Health Resources and Services Administration, Room 11C-26, Parklawn 
Building, 5600 Fishers Lane, Rockville, Maryland 20857; telephone at 
(301) 443-6593.

SUPPLEMENTARY INFORMATION: On September 13, 2010, the Secretary 
published in the Federal Register (75 FR 55503, September 13, 2010) an 
NPRM to revise and amend the Table by moving these vaccines to separate 
and distinct listings of the Table. The NPRM was issued pursuant to 
Section 2114(e) of the Act, which directs the Secretary to add to the 
Table, by rulemaking, coverage of additional vaccines which are 
recommended by the Centers for Disease Control and Prevention for 
routine administration to children.
    The Department held a 6-month comment period, which ended on March 
14, 2011, in connection with this NPRM. The Secretary received one non-
substantive comment that was not responsive to the NPRM. A public 
hearing was held on March 4, 2011, as announced in the Federal Register 
(76 FR 8965, February 16, 2011), but no individual or organization 
appeared to testify.
    Because the Secretary has not received any substantive comments, 
either written or oral, from any interested individual or organization 
on the proposals made in the NPRM, and because the Secretary continues 
to believe the advisability of effectuating such proposals, this final 
rule implements the proposals made in the NPRM. The rationale for all 
revisions were explained fully in the Preamble to the NPRM. For the 
reasons set forth in the NPRM, the Secretary amends the Table in this 
final rule.

Economic and Regulatory Impact

    Executive Order 12866, as amended by Executive Orders 13258 and 
13422, directs agencies to assess all costs and benefits of available 
regulatory alternatives and, when rulemaking is necessary, to select 
regulatory approaches that provide the greatest net benefits (including 
potential economic, environmental, public health, safety, distributive 
and equity effects). In addition, under the Regulatory Flexibility Act, 
if a rule has a significant economic effect on a substantial number of 
small entities, the Secretary must specifically consider the economic 
effect of a rule on small entities and analyze regulatory options that 
could lessen the impact of the rule. Executive Order 12866, as amended 
by Executive Orders 13258 and 13422, requires that all regulations 
reflect consideration of alternatives, of costs, of benefits, of 
incentives, of equity, and of available information. Regulations must 
meet certain standards, such as avoiding an unnecessary burden. 
Regulations which are ``significant'' because of cost, adverse effects 
on the economy, inconsistency with other agency actions, effects on the 
budget, or novel legal or policy issues, require special analysis.
    The Secretary has determined that no resources are required to 
implement the requirements in this final rule. Therefore, in accordance 
with the Regulatory Flexibility Act of 1980 (RFA), and the Small 
Business Regulatory Enforcement Fairness Act of 1996, which amended the 
RFA, the Secretary certifies that this final rule will not have a 
significant impact on a substantial number of small entities.
    The Secretary has also determined that this final rule does not 
meet the criteria for a major rule as defined by Executive Order 12866, 
as amended by Executive Orders 13258 and 13422, and would have no major 
effect on the economy or Federal expenditures. The Secretary has 
determined that this final rule is not a ``major rule'' within the 
meaning of the statute providing for Congressional Review of Agency 
Rulemaking, 5 U.S.C. 801.
    Similarly, it will not have effects on State, local, and Tribal 
governments and on the private sector such as to require consultation 
under the Unfunded Mandates Reform Act of 1995.
    The Secretary has reviewed this final rule in accordance with 
Executive Order 13132 regarding federalism, and has determined that it 
does not have ``federalism implications.'' This final rule would not 
``have substantial direct effects on the States, or on the relationship 
between the national government and the States, or on the distribution 
of power and responsibilities among the various levels of government.''
    This final rule would not adversely affect the following family 
elements: Family safety, family stability, marital commitment; parental 
rights in the education, nurture and supervision of their children; 
family functioning, disposable income or poverty; or the behavior and 
personal responsibility of youth, as determined under section 654(c) of 
the Treasury and General Government Appropriations Act of 1999.

Impact of the New Rule

    This final rule is technical in nature. Because the vaccines being 
added to the Table as separate categories are already included on the 
Table under Category XIII, this Table will have no effect on current or 
potential petitioners other than to help clarify which vaccines are 
covered by the VICP. This final rule would not prevent otherwise 
eligible individuals with claims of injuries or deaths allegedly 
resulting from the hepatitis A, trivalent influenza, meningococcal and 
human papillomavirus vaccines from filing claims with the VICP and 
would not otherwise affect such petitioners.

Paperwork Reduction Act

    This final rule does not have any information collection 
requirements.


[[Page 36368]]


    Dated: May 2, 2011.
Mary Wakefield,
Administrator, Health Resources and Services Administration.
    Approved: June 16, 2011.
Kathleen Sebelius,
Secretary.

List of Subjects in 42 CFR Part 100

    Biologics, Health insurance, and Immunization.

    Accordingly, 42 CFR part 100 is amended as set forth below:

PART 100--VACCINE INJURY COMPENSATION

0
1. The authority citation for 42 CFR part 100 continues to read as 
follows:

    Authority:  Secs. 312 and 313 of Pub. L. 99-660, 100 Stat. 3779-
3782 (42 U.S.C. 300aa-1 note); sec. 2114(c) and (e) of the PHS Act 
(42 U.S.C. 300aa-14(c) and (e)); sec. 2115(a)(3)(B) of the PHS Act 
(42 U.S.C. 300aa-15(a)(3)(B)); sec. 904(b) of Pub. L. 105-34, 111 
Stat. 873; sec. 1503 of Pub. L. 105-277, 112 Stat. 2681-741; and 
sec. 523(a) of Pub. L. 106-170, 113 Stat. 1927-1928.


0
2. Amend Sec.  100.3 by revising the Vaccine Injury Table following 
paragraph (a), revising paragraph (c)(1), redesignating paragraph 
(c)(5) as paragraph (c)(8) and revising newly designated paragraph 
(c)(8), and adding new paragraphs (c)(5), (c)(6), and (c)(7), to read 
as follows:


Sec.  100.3  Vaccine injury table

    (a) * * *

                          Vaccine Injury Table
------------------------------------------------------------------------
                                                         Time period for
                                                        first symptom or
                                                        manifestation of
                                 Illness, disability,      onset or of
            Vaccine               injury or condition      significant
                                        covered            aggravation
                                                          after vaccine
                                                         administration
------------------------------------------------------------------------
I. Vaccines containing tetanus  A. Anaphylaxis or       4 hours.
 toxoid (e.g., DTaP, DTP, DT,    anaphylactic shock.
 Td, or TT).
                                B. Brachial Neuritis..  2-28 days.
                                C. Any acute            Not applicable.
                                 complication or
                                 sequela (including
                                 death) of an illness,
                                 disability, injury,
                                 or condition referred
                                 to above which
                                 illness, disability,
                                 injury, or condition
                                 arose within the time
                                 period prescribed.
II. Vaccines containing whole   A. Anaphylaxis or       4 hours.
 cell pertussis bacteria,        anaphylactic shock.
 extracted or partial cell
 pertussis bacteria, or
 specific pertussis antigen(s)
 (e.g., DTP, DTaP, P, DTP-Hib).
                                B. Encephalopathy (or   72 hours.
                                 encephalitis).
                                C. Any acute            Not applicable.
                                 complication or
                                 sequela (including
                                 death) of an illness,
                                 disability, injury,
                                 or condition referred
                                 to above which
                                 illness, disability,
                                 injury, or condition
                                 arose within the time
                                 period prescribed.
III. Measles, mumps, and        A. Anaphylaxis or       4 hours.
 rubella vaccine or any of its   anaphylactic shock.
 components (e.g., MMR, MR, M,
 R).
                                B. Encephalopathy (or   5-15 days (not
                                 encephalitis).          less than 5
                                                         days and not
                                                         more than 15
                                                         days).
                                C. Any acute            Not applicable.
                                 complication or
                                 sequela (including
                                 death) of an illness,
                                 disability, injury,
                                 or condition referred
                                 to above which
                                 illness, disability,
                                 injury, or condition
                                 arose within the time
                                 period prescribed.
IV. Vaccines containing         A. Chronic arthritis..  7-42 days.
 rubella virus (e.g., MMR, MR,
 R).
                                B. Any acute            Not applicable.
                                 complication or
                                 sequela (including
                                 death) of an illness,
                                 disability, injury,
                                 or condition referred
                                 to above which
                                 illness, disability,
                                 injury, or condition
                                 arose within the time
                                 period prescribed.
V. Vaccines containing measles  A. Thrombocytopenic     7-30 days.
 virus (e.g., MMR, MR, M).       purpura.
                                B. Vaccine-Strain       6 months.
                                 Measles Viral
                                 Infection in an
                                 immunodeficient
                                 recipient.
                                C. Any acute            Not applicable.
                                 complication or
                                 sequela (including
                                 death) of an illness,
                                 disability, injury,
                                 or condition referred
                                 to above which
                                 illness, disability,
                                 injury, or condition
                                 arose within the time
                                 period prescribed.
VI. Vaccines containing polio   A. Paralytic Polio....  ................
 live virus (OPV).
                                   --in a non-          30 days.
                                    immunodeficient
                                    recipient.
                                   --in an              6 months.
                                    immunodeficient
                                    recipient.
                                   --in a vaccine       Not applicable.
                                    associated
                                    community case.
                                B. Vaccine-Strain
                                 Polio Viral Infection.
                                   --in a non-          30 days.
                                    immunodeficient
                                    recipient.
                                   --in an              6 months.
                                    immunodeficient
                                    recipient.
                                   --in a vaccine       Not applicable.
                                    associated
                                    community case.
                                C. Any acute            Not applicable.
                                 complication or
                                 sequela (including
                                 death) of an illness,
                                 disability, injury,
                                 or condition referred
                                 to above which
                                 illness, disability,
                                 injury, or condition
                                 arose within the time
                                 period prescribed.

[[Page 36369]]

 
VII. Vaccines containing polio  A. Anaphylaxis or       4 hours
 inactivated virus (e.g., IPV).  anaphylactic shock.
                                B. Any acute            Not applicable.
                                 complication or
                                 sequela (including
                                 death of an illness,
                                 disability, injury,
                                 or condition referred
                                 to above which
                                 illness, disability,
                                 injury, or condition
                                 arose within the time
                                 period prescribed..
VIII. Hepatitis B. vaccines...  A. Anaphylaxis or       4 hours.
                                 anaphylactic shock.
                                B. Any acute            Not applicable.
                                 complication or
                                 sequela (including
                                 death) of an illness,
                                 disability, injury,
                                 or condition referred
                                 to above which
                                 illness, disability,
                                 injury, or condition
                                 arose within the time
                                 period prescribed.
IX. Hemophilus influenzae type  No Condition Specified  Not applicable.
 b polysaccharide conjugate
 vaccines.
X. Varicella vaccine..........  No Condition Specified  Not applicable.
XI. Rotavirus vaccine.........  No Condition Specified  Not applicable.
XII. Pneumococcal conjugate     No Condition Specified  Not applicable.
 vaccines.
XIII. Hepatitis A vaccines....  No Condition Specified  Not applicable.
XIV. Trivalent influenza        No Condition Specified  Not applicable.
 vaccines.
XV. Meningococcal vaccines....  No Condition Specified  Not applicable.
XVI. Human papillomavirus       No Condition Specified  Not applicable.
 (HPV) vaccines.
XVII. Any new vaccine           No Condition Specified  Not applicable.
 recommended by the Centers
 for Disease Control and
 Prevention for routine
 administration to children,
 after publication by the
 Secretary of a notice of
 coverage.
------------------------------------------------------------------------

* * * * *
    (c) * * * (1) Except as provided in paragraph (c)(2), (3), (4), 
(5), (6), or (7) of this section, the revised Table of Injuries set 
forth in paragraph (a) of this section and the Qualifications and Aids 
to Interpretation set forth in paragraph (b) of this section apply to 
petitions for compensation under the Program filed with the United 
States Court of Federal Claims on or after March 24, 1997. Petitions 
for compensation filed before such date shall be governed by section 
2114(a) and (b) of the Public Health Service Act as in effect on 
January 1, 1995, or by Sec.  100.3 as in effect on March 10, 1995 (see 
60 FR 7678, et seq., February 8, 1995), as applicable.
* * * * *
    (5) Hepatitis A vaccines (Item XIII of the Table) are included on 
the Table as of December 1, 2004.
    (6) Trivalent influenza vaccines (Item XIV of the Table) are 
included on the Table as of July 1, 2005.
    (7) Meningococcal vaccines and human papillomavirus vaccines (Items 
XV and XVI of the Table) are included on the Table as of February 1, 
2007.
    (8) Other new vaccines (Item XVII of the Table) will be included in 
the Table as of the effective date of a tax enacted to provide funds 
for compensation paid with respect to such vaccines. An amendment to 
this section will be published in the Federal Register to announce the 
effective date of such a tax.
* * * * *
[FR Doc. 2011-15617 Filed 6-21-11; 8:45 am]
BILLING CODE 4165-15-P